Insights+: The US FDA New Drug Approvals in September 2021

The US FDA has approved 5 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 55 novel products in 2021 Additionally, last year in 2020, the US FDA…

BySenior EditorOctober 21, 2021

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PharmaShots Interview: Xencor’s Bassil I. Dahiyat Shares Insight on the US FDA’s Approval of COVID-19 Antibody Treatment Leveraging its Technology

In an interview with PharmaShots, Dr. Bassil I. Dahiyat, President and CEO of Xencor shared his views on the company's collaborations with BMS and its Xtend XmAb technology. He also shed light on the EUA of Sotrovimab for COVID-19. Shots: The FDA has granted EUA to Vir and GSK's sotrovimab, which was engineered with Xencor's XmAb…

BySenior EditorAugust 3, 2021

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PharmaShots Interview: Myovant’s Dave Marek Shares Insights on the US FDA’s Approval of Myfembree in Uterine Fibroids

In an interview with PharmaShots, Dave Marek. CEO of Myovant shares insights on the US FDA's approval of Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) in Uterine Fibroids. Shots: The US FDA has approved Myovant & Pfizer's Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as the first once-daily treatment for the…

BySenior EditorJuly 20, 2021

EVENTS

12th Summit on Biosimilars & Innovator Biologics

June 22 ' 23, 2021 (EDT) | Virtual Conference The American Conference Institute invites you to attend the Virtual 12th Summit on Biosimilars & Innovator Biologics on June 22-23, 2021! Gain government and industry insights on the Innovator and Biosimilars Marketplace from the U.S. FTC, U.S. FDA, USPTO, and leading In-House Counsel. As the number…

BySenior EditorApril 30, 2021

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PharmaShots Interview: Dr. Sezer, Peter C. Adamson and Israel Lowy Share Insight on the US FDA’s Approval of Libtayo (cemiplimab) in Patients with NSCLC with High PD-L1 Expression

Shots: In an interview with PharmaShots, Dr. Ahmet Sezer, Sanofi's Peter C. Adamson, and Regeneron's Israel Lowy shared their views on the US FDA's approval of Libtayo and the data supporting the approval. Regeneron and Sanofi received the US FDA's approval for Libtayo for the 1L treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score =50%), as…

BySenior EditorMarch 30, 2021

INSIGHTS+

Insights+: The US FDA New Drug Approvals in February 2021

The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 12 novel products in 2021. Additionally, last year in 2020, the US…

BySenior EditorMarch 18, 2021

INSIGHTS+

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available…

BySenior EditorMarch 11, 2021

INSIGHTS+

Insights+: The US FDA New Drug Approvals in January 2021

The US FDA has approved 4 NDAs in Jan 2021, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 4 novel products in 2021. Additionally, last year in 2020, the US FDA has approved…

BySenior EditorFebruary 18, 2021

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PharmaShots Interview: BoneHealth Technologies’ Laura Yecies Shares Insights on OsteoBoost Vibration Belt

In a recent interview with PharmaShots, Laura Yecies, CEO of BoneHealth Technologies shared her views on OsteoBoost Vibration Belt that has been granted 'Breakthrough Device' designation by the US FDA Shots: OsteoBoost receives the US FDA's BDD to reduce the risk of osteoporosis. It uses vibration technology that delivers mechanical stimulation to the hips & spine at…

BySenior EditorFebruary 2, 2021

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PharmaShots Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

In a recent interview with PharmaShots, Ted Omachi, Global Development Leader for Xolair, and Senior Medical Director of Product Development for Immunology, Genentech shared his views on the approval of Xolair in the US. Shots: The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with…

BySenior EditorJanuary 6, 2021

Insights+: The US FDA New Drug Approvals in September 2021

PharmaShots Interview: Xencor’s Bassil I. Dahiyat Shares Insight on the US FDA’s Approval of COVID-19 Antibody Treatment Leveraging its Technology

PharmaShots Interview: Myovant’s Dave Marek Shares Insights on the US FDA’s Approval of Myfembree in Uterine Fibroids

12th Summit on Biosimilars & Innovator Biologics

Insights+: The US FDA New Drug Approvals in February 2021

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

Insights+: The US FDA New Drug Approvals in January 2021

PharmaShots Interview: BoneHealth Technologies’ Laura Yecies Shares Insights on OsteoBoost Vibration Belt

PharmaShots Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

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